Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit

• Status: Not yet recruiting
• Trial end date: 2026-06-06
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy of cotrimoxazole as a de-escalation treatment for adult patients Ventilator-Associated Pneumonia in intensive care unit Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anti-Bacterial Agents; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Adult patients hospitalized in an ICU

• Under mechanical ventilation for at least five days

• Microbiologically confirmed VAP on a distal lung sample (bronchoalveolar lavage or protected distal specimen)

• Enterobacteriaceae susceptible to cotrimoxazole, and for polymicrobial VAP, all bacteria susceptible to cotrimoxazole

Exclusion Criteria:

• Haemodynamic instability (increasing dose of a catecholamine in the last 24 hours)

• Contra-indication to cotrimoxazole:

• allergy,

• advanced liver insufficiency,

• renal dysfunction with clearance <15 mL/min/1.73 m² without hemodialysis

• G6PD deficiency

• Pregnant women at the time of inclusion and breastfeeding women

• Infection requiring prolonged antibiotic-therapy (pleural empyema, lung abscess, necrotizing pneumonia, etc…)

• Cystic fibrosis

• Immunosuppression (neutropenia, HIV with CD4 lymphocytes below 200/mm3, immunosuppressive therapy or corticosteroid therapy >0.5 mg/kg/j before ICU admission)

• Cardiac arrest without awakening

• Moribund state (patient likely to die within 24h)

• Limitation of life support (comfort care applied only) at the time of screening

• Enrolment to another interventional study on VAP care/management

• Subject deprived of freedom, subject under a legal protective measure

• No affiliation to any health insurance system

• Refusal to participate to the study (patient or legal representative or family member or close relative if present) Patients previously included in the study